CQV Lead

OverviewThis role provides leadership and oversight for the full Commissioning & Qualification (C&Q) program on a major pharmaceutical facility project. The project follows a Verification-based methodology aligned with the ASTM E2500 model, integrating commissioning and qualification activities throughout the project lifecycle—from early design through system turnover and closeout. The organization uses Kneat™ for electronic C&Q document development and execution.Purpose of the RoleThe C&Q Lead is responsible for the overall management and delivery of the project's C&Q scope, including managing scope, schedule, and budget; implementing the C&Q program; leading FATs, test case development, and field execution; providing technical oversight; and ensuring safety compliance.Key ResponsibilitiesDevelop and manage the C&Q delivery strategy and schedule.Ensure technical excellence and compliance throughout C&Q activities.Coordinate with cross-functional teams to resolve technical and compliance issues.Review and understand the organization's C&Q program to train and guide the project team.Lead the C&Q team, including daily meetings, task assignments, and workload management.Escalate unresolved issues such as delayed approvals or field execution challenges.Plan and manage FAT execution, test case development, and field testing logistics.Define staffing levels, travel requirements, test equipment needs, and craft labor support.Maintain safety oversight and ensure adherence to all safety and permitting procedures.Collaborate with automation, construction, engineering, QA, and end-user groups.Provide monthly progress metrics to project leadership.Role RequirementsBachelor's degree in Engineering or equivalent experience.15+ years of C&Q experience on major or mega pharmaceutical capital projects.Experience delivering at least one full lifecycle Brownfield or Greenfield pharmaceutical facility.Demonstrated leadership and people management capabilities.Strong knowledge of GMPs, regulatory expectations, commissioning and qualification practices, and ASTM E2500 Verification methodology.Excellent written and verbal communication skills.Ability to work onsite full time and travel as required.